AMINOSYN-PF 7%
Clinical safety rating: caution
Comprehensive clinical and safety monograph for AMINOSYN-PF 7% (AMINOSYN-PF 7%).
Aminosyn-PF 7% is a crystalline amino acid solution that provides essential and non-essential amino acids for protein synthesis, thereby maintaining nitrogen balance and supporting tissue repair and growth in parenteral nutrition.
| Metabolism | Amino acids are metabolized via transamination, deamination, and oxidation in various tissues, with the liver playing a central role in nitrogen handling and urea cycle metabolism. |
| Excretion | Amino acids are primarily cleared by metabolism; less than 10% is excreted unchanged in urine. |
| Half-life | As a mixture of amino acids, individual amino acids have half-lives ranging from minutes to hours; clinically, continuous infusion maintains steady state. |
| Protein binding | Minimal (<10%); individual amino acids may bind weakly to albumin. |
| Volume of Distribution | Variable per amino acid; total body water (~0.6 L/kg). |
| Bioavailability | Intravenous: 100% (only route of administration). |
| Onset of Action | Intravenous: Plasma amino acid levels rise within minutes to hours; clinical effect (nitrogen balance improvement) occurs within 24–48 hours. |
| Duration of Action | Duration is dependent on infusion rate; plasma levels decline rapidly after discontinuation (within hours). |
Intravenous infusion; typical adult dose: 1-2 g amino acids/kg/day (e.g., 14-28 mL/kg/day for 7% solution) as part of parenteral nutrition. Infusion rate not to exceed 0.1 g amino acids/kg/hour.
| Dosage form | INJECTABLE |
| Renal impairment | For GFR < 50 mL/min: reduce to 0.5-1 g amino acids/kg/day and monitor BUN and electrolytes; avoid or use with caution in severe renal impairment (GFR < 25 mL/min) due to risk of azotemia. |
| Liver impairment | Child-Pugh Class B or C: contraindicated or use with extreme caution; reduce dose to 0.5-1 g amino acids/kg/day and monitor for encephalopathy; avoid in decompensated liver disease. |
| Pediatric use | Term neonates and children: initial dose 1-2 g amino acids/kg/day (14-28 mL/kg/day of 7% solution) via central or peripheral IV; increase gradually to maximum 2-3 g/kg/day based on tolerance and metabolic status. |
| Geriatric use | Elderly patients: start at lower end of dosing range (1 g amino acids/kg/day) due to reduced renal function and metabolic reserve; monitor fluid and electrolyte balance closely; adjust based on renal function and clinical status. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for AMINOSYN-PF 7% (AMINOSYN-PF 7%).
| Breastfeeding | Excretion of amino acids into breast milk has not been studied. Caution is advised. No M/P ratio available. Consider maternal nutritional status and potential benefits versus risks. |
| Teratogenic Risk | Aminosyn-PF 7% is a crystalline amino acid solution used in parenteral nutrition. No adequate and well-controlled studies in pregnant women. Animal reproduction studies have not been conducted. Potential fetal risks depend on maternal metabolic status and underlying condition. Use only if clearly needed. First trimester: Theoretical risk of amino acid imbalances affecting embryogenesis; no specific teratogenic data. Second and third trimesters: May be used to correct maternal malnutrition; however, fluid and electrolyte imbalances must be avoided to prevent fetal acidosis or electrolyte disturbances. |
■ FDA Black Box Warning
None.
| Serious Effects |
["Hypersensitivity to any component of the formulation.","Inborn errors of amino acid metabolism.","Severe hepatic failure or hepatic coma.","Severe renal impairment without appropriate protein restriction.","Uncompensated heart failure or fluid overload."]
| Precautions | ["Risk of metabolic acidosis, hyperammonemia, and azotemia, especially in patients with hepatic or renal impairment.","Monitor serum electrolytes, blood glucose, liver function, and acid-base balance regularly.","Do not administer simultaneously with blood products through the same infusion line due to risk of aggregation."] |
| Food/Dietary | No known food interactions as this drug is given intravenously. However, enteral intake should be optimized to transition to oral feeds when tolerated. |
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| Fetal Monitoring | Monitor maternal serum electrolytes, blood urea nitrogen (BUN), creatinine, blood glucose, acid-base balance, liver function tests, and plasma ammonia levels. Assess maternal weight gain and fluid balance. Fetal monitoring may include ultrasound for growth and amniotic fluid assessment in prolonged use. |
| Fertility Effects | No data on fertility effects. Parenteral nutrition may correct nutritional deficiencies that could impair fertility; however, specific effects on human reproduction have not been studied. |
| Clinical Pearls | Aminosyn-PF 7% is a pediatric amino acid solution formulated for infants and children. It contains lower concentrations of electrolytes to minimize risk of hyperkalemia and hyperphosphatemia in neonates. Use with caution in renal/hepatic impairment. Monitor serum electrolytes, BUN, and ammonia regularly. Avoid rapid infusion; administer via central line to reduce thrombophlebitis risk. Do not exceed 3.5 g/kg/day in preterm infants to prevent hyperammonemia. |
| Patient Advice | This medication provides essential amino acids for growth and development. · It is administered intravenously, usually through a central line. · Report any signs of infection at the IV site (redness, swelling, pain). · Regular blood tests are required to monitor kidney, liver, and electrolyte levels. · Do not stop or change the infusion rate without consulting a doctor. |